ZENINAS FILM-COATED TABLETS

Introduction

Leaflet: Information for the user

Zeninas film-coated tablets

Powder ofAloe ferox(Aloe)/Extract ofRhamnus purshianusD.C(Sacred Bark)

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist. If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 4 days.

Contents of the leaflet

1. What Zeninas film-coated tablets are and what they are used for
2. What you need to know before taking Zeninas film-coated tablets
3. How to take Zeninas film-coated tablets
4. Possible side effects
5. Storage of Zeninas film-coated tablets

1. Package contents and additional information

1. What Zeninas film-coated tablets are and what they are used for

Zeninas film-coated tablets are a stimulant laxative. The laxative effects are produced by an increase in colon movement and stimulation of fluid secretion processes, favoring the evacuation of feces.

Zeninas film-coated tablets are a plant-based medication for the treatment of occasional constipation.

You should consult a doctor if your condition worsens or does not improve after 4 days.

2. What you need to know before taking Zeninas film-coated tablets

Do not take Zeninas film-coated tablets

• If you are allergic (hypersensitive) to Cape Aloe (Aloe ferox), Sacred Bark (Rhamnus purshianus), or any of the other components of this medication (listed in section 6).
• If you have appendicitis or symptoms of appendicitis such as nausea, vomiting, cramps, or abdominal pain.
• If you have intestinal problems such as: undiagnosed rectal bleeding, intestinal obstruction, hemorrhoids; inflammatory abdominal disease (such as Crohn's disease and ulcerative colitis); intestinal atony; and in severe states of dehydration with reduced water and electrolytes.
• If you have severe liver or kidney disease.
• If you have congestive heart failure (the heart does not pump enough blood).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zeninas film-coated tablets.

• Do not use more than the recommended dose in section 3 "How to take Zeninas film-coated tablets".
• Before using laxatives for the treatment of constipation, a treatment with high-fiber foods or concentrated fiber should be tried.
• Prolonged consumption of laxatives should be avoided. If constipation or irregularities in bowel movements persist for more than four days, the clinical situation should be examined. Prolonged treatments can produce tolerance (habituation) to the laxative effect and dependence (need) for it to achieve evacuation, as well as disorders in water and electrolyte metabolism.

If this medication is administered to dependent patients, they should have frequent diaper changes to avoid prolonged contact with feces.

Use of other medications and Zeninas film-coated tablets

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those purchased without a prescription.

Patients undergoing treatment with cardiac glycosides, antiarrhythmics, medications that prolong the QT curve (quinidine), diuretics (medications that facilitate and increase urine elimination) or licorice root, antibiotics (used to treat infections), medications to treat stomach acidity (antacids) such as cimetidine, famotidine, and ranitidine, potassium supplements. Indomethacin, acetylsalicylic acid, and other prostaglandin synthesis inhibitors should consult their doctor before taking this medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

This preparation is eliminated in small amounts in breast milk, and although there are no data on the possible laxative effects it may have on infants, its use is not recommended in these circumstances.

Driving and using machines

No effects on the ability to drive or use machines have been described at the recommended doses.

3. How to take Zeninas film-coated tablets

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 12 years:1 film-coated tablet per day.

Use in children

Do not use this medication in children under 12 years.

Use in people over 65 years

Older adults should not take this medication without consulting their doctor, as they are more likely to experience its side effects.

Method of administration

This medication is administered orally.

The Zeninas film-coated tablet is swallowed with a glass of water, preferably one hour after dinner and before bedtime; the laxative effect will generally be observed the next morning.

• Take the medication with meals or with milk, especially if you notice digestive discomfort. Do not take this medication on an empty stomach.

If constipation persists for more than 4 days, or if symptoms worsen or others appear, you should interrupt treatment and consult your doctor.

If you take more Zeninas film-coated tablets than you should

If you have taken more Zeninas film-coated tablets than you should, consult your doctor or pharmacist immediately. The main symptoms of overdose are: massive diarrhea with water and salt loss.

If it is severe, it can cause confusion, cardiac arrhythmia, cramps, fatigue, or weakness, which can be more pronounced in older people.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take Zeninas film-coated tablets

Do not take a double dose to make up for forgotten doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

The side effects of the medication are mild and transient.

Digestive, gastrointestinal, abdominal pain, colic-type, belching, and intestinal cramps may appear. The urine may turn pink-yellow to brown, which is of no importance and is due to the elimination of the medication's components.

If you consider that any of the side effects you are experiencing is serious or if you notice any other side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Zeninas film-coated tablets

Keep out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use Zeninas film-coated tablets if you observe any signs of deterioration in the inner packaging that contains the film-coated tablets.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Zeninas film-coated tablets

• The active ingredients are:
• • Powder of Aloe ferox(Aloe): approximately 51.72 mg - 92.59 mg (equivalent to 15 mg of hydroxyanthracene derivatives).
  • Dry standardized extract of Rhamnus purshianusD.C (Sacred Bark): approximately 60 mg - 78.95 mg (equivalent to 15 mg of hydroxyanthracene derivatives). DER (4-6:1). Ethanol 60% v/v.

• The other components (excipients) are:

Core: licorice, microcrystalline cellulose, sodium croscarmellose, colloidal silicon dioxide, magnesium stearate, and purified water.

Coating: Vivacoat PA, which contains hypromellose, polydextrose, talc, red iron oxide, black iron oxide, titanium dioxide, polyethylene glycol 3350, yellow iron oxide, and indigo dye.

Appearance of the product and package contents

Brown, round, and convex film-coated tablet.

It is presented in formats of 30 film-coated tablets packaged in PVC/PVDC/AL blister packs.

Marketing authorization holder

Vemedia Manufacturing B.V. Verrijn Stuartweg 60

NL-1112 AX Diemen

Netherlands

Local representative:

Vemedia Pharma Hispania S.A.

C/Aragón 182 5ª planta

08011 Barcelona

Spain

Manufacturer

Vemedia Manufacturing B.V. Verrijn Stuartweg 60

NL-1112 AX Diemen

Netherlands

Laboratorium Sanitatis, S.L.

Parque Tecnológico de Álava

Leonardo Da Vinci, 11

E-01510 Miñano – Araba / Álava (Spain)

This leaflet was approved in September 2020

Date of the last revision of this leaflet:

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/